Verrica Pharmaceuticals Submits New Drug Application to U.S. Food and Drug Administration for VP-102 for the Treatment of Mol...
September 16 2019 - 7:00AM
Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a
medical dermatology company committed to the development and
commercialization of novel treatments that provide meaningful
benefit for people living with skin diseases, today announced that
it has submitted a New Drug Application (NDA) to the U.S. Food and
Drug Administration (FDA) for VP-102 (cantharidin 0.7% Topical
Solution), a proprietary topical therapy, for the treatment of
molluscum contagiosum (molluscum). No FDA-approved treatments are
currently available for molluscum, a common, highly contagious skin
disease affecting an estimated 6 million people in the United
States, primarily children. Without treatment, molluscum can
persist for an average of 13 months, with some cases remaining
unresolved for several years.
“Molluscum is a viral skin infection that is highly contagious,
spreads rapidly, and is significantly undertreated, with no
FDA-approved therapeutic options,” said Ted White, President and
Chief Executive Officer, Verrica. “The NDA submission potentially
brings us one step closer to our goal of providing patients —
particularly children and their caregivers — with a safe and
effective therapy for molluscum with our proprietary single-use
applicator. If approved, VP-102 has the potential to become the
standard of care for this disease.”
The 505(b)(1) NDA is supported by the positive results from two
double-blind Phase 3 trials (CAMP-1 and CAMP-2) that evaluated the
safety and efficacy of VP-102 compared to placebo in patients two
years of age and older diagnosed with molluscum. The CAMP-1 and
CAMP-2 studies enrolled 528 patients in total and were conducted at
31 centers in the United States. Each trial demonstrated superior
efficacy of VP-102 compared to placebo with statistically
significant differences on the primary endpoint of complete
clearance of all treatable molluscum lesions. Specific results from
CAMP-1 and CAMP-2 demonstrated 46% and 54%, respectively, of
subjects treated with VP-102 achieved complete clearance at day 84,
versus 18% and 13% of subjects in the placebo groups (p<0.0001).
By the end of the trials (Day 84), VP-102 treated subjects had a
69% and 83% mean reduction in molluscum lesions, a pre-specified
endpoint, in CAMP-1 and CAMP-2, respectively, compared to a 20%
increase and 19% reduction for subjects on placebo. VP-102 was
well-tolerated in both trials, with no serious adverse events
reported in VP-102 treated subjects.
Verrica has been granted a waiver by the FDA for the NDA
application user fee under the small business waiver provision of
the Federal Food, Drug and Cosmetic Act.
About Verrica Pharmaceuticals Inc.
Verrica is a medical dermatology company committed to the
development and commercialization of novel treatments that provide
meaningful benefit for people living with skin diseases. The
company’s late-stage product candidate, VP-102, is a potential
first-in-class topical therapy for the treatment of molluscum
contagiosum and common warts. Molluscum is a highly contagious
viral skin infection affecting approximately six million people,
primarily children, in the United States, and common warts are
contagious skin growths affecting 22 million people. There are
currently no FDA-approved treatments for molluscum or common
warts. Following positive topline results from two pivotal Phase 3
trials, the company submitted a NDA for VP-102 for the treatment of
molluscum. Verrica is planning to meet with the FDA to
determine next steps on the development of VP-102 for common warts
following positive Phase 2 results. VP-102 is also currently in a
Phase 2 trial for the treatment of external genital warts. A second
product candidate, VP-103, is in pre-clinical development for
plantar warts. For more information,
visit www.verrica.com.
Forward-Looking Statement
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. These statements may be identified by words such as
“believe,” “expect,” “may,” “plan,” “potential,” “will,” and
similar expressions, and are based on Verrica’s current beliefs and
expectations. These forward-looking statements include expectations
regarding the potential benefits of VP-102 for the treatment of
molluscum and the clinical development of VP-102 for additional
indications. These statements involve risks and uncertainties that
could cause actual results to differ materially from those
reflected in such statements. Risks and uncertainties that may
cause actual results to differ materially include uncertainties
inherent in the drug development process and the regulatory
approval process, Verrica’s reliance on third parties over which it
may not always have full control, and other risks and uncertainties
that are described in Verrica’s Annual Report on Form 10-K for the
year ended December 31, 2018, filed with the U.S. Securities and
Exchange Commission on March 7, 2019, and other filings Verrica
makes with the U.S. Securities and Exchange Commission. Any
forward-looking statements speak only as of the date of this press
release and are based on information available to Verrica as of the
date of this release, and Verrica assumes no obligation to, and
does not intend to, update any forward-looking statements, whether
as a result of new information, future events or otherwise.
FOR MORE INFORMATION, PLEASE CONTACT:
Contacts
Investors:
Chris DegnanChief Financial
Officer484.453.3300 ext. 103info@verrica.com
Chiara RussoSolebury
Trout617.221.9197crusso@soleburytrout.com
Media:
Joshua R. MansbachSolebury
Trout646-378-2964jmansbach@troutgroup.com
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